Carlsmed, Inc. (CARL) 2026 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Carlsmed first-quarter 2026 earnings conference call. (Operator Instructions)

各位女士、先生，感謝您稍候，歡迎參加 Carlsmed 2026 年第一季財報電話會議。(接線員指示)

I would now like to turn the conference over to your first speaker today, Stephanie Zhadkevich.

現在我想把會議交給今天的第一位講者 Stephanie Zhadkevich。

Thank you, operator. Welcome to Carlsmed's first-quarter 2026 earnings call. Joining me on today's call are Mike Cordonnier, Chairman and Chief Executive Officer; and Leo Greenstein, Chief Financial Officer. Before we begin, I would like to caution that comments made during this call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

謝謝，接線員。歡迎參加 Carlsmed 2026 年第一季財報電話會議。今天與我一同出席的有董事長兼執行長 Mike Cordonnier，以及財務長 Leo Greenstein。在開始之前，我想提醒各位，本次電話會議中的評論將包含《1995 年私人證券訴訟改革法》所定義的前瞻性陳述。

All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the market in which Carlsmed operates, trends, expectations, and demand for Carlsmed's products, expectations with respect to reimbursement, statements about the company's clinical data, surgeon adoption and utilization and Carlsmed's expected financial performance and position in the market.

本次電話會議中所有不涉及歷史事實的陳述，均應視為前瞻性陳述，包括關於 Carlsmed 所處市場、趨勢、預期，以及對 Carlsmed 產品的需求；對給付/報銷的預期；關於公司臨床數據的陳述；外科醫師採用與使用情況；以及 Carlsmed 預期的財務表現與市場地位等陳述。

Any forward-looking statements made during this call, including projections for future performance, is based on management's expectations as of today. Carlsmed undertakes no obligation to update these statements, except as required by applicable laws. These statements are neither promises nor guarantees and are subject to known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements.

本次電話會議中所作的任何前瞻性陳述（包括對未來表現的預測）均基於管理層截至今日的預期。除非適用法律要求，Carlsmed 不承擔更新這些陳述的任何義務。這些陳述既非承諾亦非保證，且受已知與未知的風險與不確定性影響，可能導致實際結果、表現或成就與前瞻性陳述所明示或暗示者存在重大差異。

For more detailed information, please review the cautionary notes on the earnings materials accompanying today's presentation as well as Carlsmed's filings with the SEC, particularly the risk factors described in Carlsmed's annual report on Form 10-K for the year ended December 31, 2025. I encourage you to review all Carlsmed's filings with the SEC concerning these and other matters.

如需更詳細資訊，請查閱今日簡報所附之財報資料中的警示說明，以及 Carlsmed 向美國證券交易委員會（SEC）提交的文件，特別是 Carlsmed 截至 2025 年 12 月 31 日止年度之 Form 10-K 年報中所述的風險因素。我鼓勵各位查閱 Carlsmed 向 SEC 提交、涉及上述及其他事項的所有文件。

Additionally, during today's call, management will discuss certain non-GAAP financial measures, including adjusted EBITDA. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures is included in today's earnings press release.

此外，在今天的電話會議中，管理層將討論若干非 GAAP 財務衡量指標，包括調整後 EBITDA。這些非 GAAP 財務衡量指標與最直接可比的 GAAP 財務衡量指標之調節表，已包含於今日的財報新聞稿中。

These filings, along with Carlsmed's press release for the first quarter 2026 results, are available on Carlsmed's website at www.carlsmed.com under the Investors section and include additional information about Carlsmed's financial results. A recording of today's call will also be available on Carlsmed's website by 5:00 p.m. Pacific Time today.

上述文件以及 Carlsmed 2026 年第一季業績新聞稿，可於 Carlsmed 官網 www.carlsmed.com 的「投資人」專區取得，並包含關於 Carlsmed 財務結果的更多資訊。今日電話會議的錄音也將於今日太平洋時間下午 5:00 前在 Carlsmed 官網提供。

Now I would like to turn the call over to Mike to go over Carlsmed's business highlights.

現在我想把電話交給 Mike，請他說明 Carlsmed 的業務重點。

Thank you, Stephanie, and welcome to the team. I would like to welcome everyone on our call today. At Carlsmed, our mission is to improve outcomes and decrease the cost of health care for spine surgery and beyond. To achieve this mission, we have pioneered patient-specific digital surgery for lumbar and cervical spine fusion procedures.

謝謝你，Stephanie，也歡迎加入團隊。我也歡迎各位今天參與我們的電話會議。在 Carlsmed，我們的使命是改善脊椎手術及更廣泛醫療領域的治療結果，並降低醫療成本。為了達成此使命，我們率先開創了針對腰椎與頸椎融合手術的病患專屬數位手術。

Our vision is to make personalized surgery at scale the standard of care for spine surgery. Our AI-enabled digital surgery platform empowers surgeons to partner closely with patients to seamlessly create three-dimensional surgical plans and 3D-printed spine fusion devices designed to achieve predictable patient outcomes while supporting the surgeon's preferred surgical approach.

我們的願景是讓可規模化的個人化手術成為脊椎手術的標準照護。我們的 AI 驅動數位手術平台，使外科醫師能與病患緊密合作，順暢地建立三維手術計畫，並製作 3D 列印的脊椎融合裝置，以在支持外科醫師偏好的手術方式之同時，達成可預測的病患治療結果。

We then provide postoperative outcome analytics to our surgeon users for each procedure through our aprevo insights as part of the myaprevo ecosystem. We believe this personalized outcome-driven AI-enabled ecosystem approach represents the future standard in medical technology, one that is better for patients, surgeons, hospitals and payers.

接著，我們透過 myaprevo 生態系中的 aprevo insights，為外科醫師使用者提供每一例手術的術後結果分析。我們相信，這種以個人化、結果導向且由 AI 賦能的生態系方法，代表醫療科技未來的標準——對病患、外科醫師、醫院與支付方都更有利。

Importantly, our model is built to scale efficiently. By manufacturing only what is needed for each specific procedure, we avoid the traditional prebuilt inventory trays of implants and instruments that have long burdened the legacy spine and orthopedics businesses. Instead, we're able to provide patient-specific, sterile-packed implants and instruments specific to each patient just in time for their surgery.

重要的是，我們的模式可有效率地擴張規模。透過僅為每一個特定手術製造所需產品，我們避免了傳統預先建置的植入物與器械庫存托盤——這些長期以來一直是傳統脊椎與骨科業務的負擔。相反地，我們能在手術前及時提供針對每位病患的專屬、無菌包裝的植入物與器械。

This capital-light demand-driven approach enables us to scale rapidly while maintaining a relentless focus on patient outcomes. With this vision as our guide, 2026 is off to a great start with solid execution across our business. In the first quarter, we saw strong adoption of our lumbar and cervical personalized surgery procedures, reinforcing our view that aprevo as a platform technology is positioned to transform spine surgery.

這種輕資本、需求驅動的方法，使我們能在保持對病患治療結果高度專注的同時快速擴張。在此願景指引下，2026 年開局良好，我們在各項業務上均展現穩健執行力。第一季，我們的腰椎與頸椎個人化手術流程採用度強勁，進一步強化我們的看法：aprevo 作為平台型技術，具備改變脊椎手術的定位。

Our clinical outcome data continues to be robust, and our investments in technology continue to drive the scale and productivity needed to make personalized surgery the standard of care for spine fusion procedures. With the peer-reviewed data published on reduced reoperations with aprevo personalized surgery procedures, we continue to execute on our mission to improve outcomes and decrease the cost of health care for spine surgery.

我們的臨床結果數據持續穩健，而我們在技術上的投資也持續推動規模化與生產力提升，這些都是讓個人化手術成為脊椎融合手術標準照護所需的關鍵。隨著同儕審查數據發表，顯示採用 aprevo 個人化手術流程可降低再手術率，我們持續落實使命：改善脊椎手術治療結果並降低醫療成本。

Turning to the first quarter. We delivered strong revenue of $16.1 million, representing growth of 58% over the prior year. Our growth was driven by the continued focus on medical education and compelling clinical outcome data, driving expansion of our surgeon base and increasing procedure volumes.

接著談第一季表現。我們實現強勁營收 1,610 萬美元，較去年同期成長 58%。成長動能來自我們持續聚焦醫學教育與具說服力的臨床結果數據，帶動外科醫師客群擴張並提升手術量。

Operationally, we continue to leverage our investments in technology to further drive production efficiencies, reducing lead time by more than 30% to 6 business days in the quarter and delivering more than 200 basis points of margin expansion year-over-year. Our fully integrated digital production system allows us to partner with hospitals, surgeons and patients to seamlessly integrate into clinic and operating room workflows preoperatively intraoperatively and postoperatively for nearly all indicated patients.

在營運方面，我們持續運用對技術的投資以進一步提升生產效率，本季將交付前置時間縮短逾 30% 至 6 個工作天，並帶來年對年超過 200 個基點的毛利率擴張。我們完全整合的數位化生產系統，使我們能與醫院、外科醫師及病患合作，於術前、術中與術後順暢地整合至門診與手術室工作流程，涵蓋幾乎所有適應症病患。

Our commercial growth continues to be driven by a surgeon-led adoption model and expanding utilization. I'm proud to report that we grew our total surgeon user base by more than 60% year-over-year, reflective of the rapid clinical adoption of personalized surgery procedures. We continue to drive particularly strong engagement from early career and post-fellowship surgeons who are eager to adopt new technology to differentiate their practices and improve outcomes.

我們的商業成長持續由「外科醫師帶動」的採用模式與使用量提升所驅動。我很自豪地報告，我們的外科醫師使用者總數年對年成長超過 60%，反映個人化手術流程的快速臨床採用。我們持續看到職涯早期與完成專科訓練後（post-fellowship）的外科醫師特別高度投入，他們渴望採用新技術以差異化其執業並改善治療結果。

With our rapidly growing base of surgeon users, we're still in the early innings of market penetration and have a long runway ahead of us. The aprevo lumbar procedure represents the majority of our business today, where we continue to gain traction within the estimated 445,000 lumbar spine fusion procedures performed annually in the US. Clinical evidence generation continues to support the early adoption of aprevo by consistently demonstrating improved outcomes for patients compared to stock implants.

隨著外科醫師使用者基礎快速成長，我們在市場滲透上仍處於早期階段，未來仍有很長的成長跑道。aprevo 腰椎手術目前占我們業務的大宗，我們持續在美國每年估計 445,000 例腰椎融合手術的市場中取得進展。臨床證據的持續累積也支持 aprevo 的早期採用，並一貫顯示相較於標準庫存植入物，病患可獲得更佳的治療結果。

In January, data published in the Global Spine Journal further validated our personalized spine surgery approach, including evidence demonstrating a 74% reduction in surgery revision rates at two years compared to stock devices. This peer-reviewed study compared two-year revision rates among complex adult spinal deformity patients receiving Carlsmed's aprevo personalized interbody implants with previously published revision data from a similar patient cohort receiving conventional stock implants.

1 月份，《Global Spine Journal》發表的數據進一步驗證我們的個人化脊椎手術方法，包括證據顯示與標準庫存裝置相比，兩年期手術翻修率降低 74%。這項同儕審查研究比較了接受 Carlsmed aprevo 個人化椎間融合植入物之複雜成人脊柱畸形病患的兩年翻修率，並與先前發表、接受傳統標準庫存植入物之相似病患族群的翻修數據進行對照。

Patients treated with aprevo experienced significantly fewer revisions due to mechanical complications, showing a revision rate of 4.3% in patients treated with aprevo compared to a revision rate of 16.6% of patients who had stock devices. To put this into perspective, over the past 25 years, lumbar fusion technologies have not published data to demonstrate significant reduction in reoperation rates at the standard two-year benchmark.

接受 aprevo 治療的病患因機械性併發症而需要翻修的情況顯著較少：aprevo 治療病患的翻修率為 4.3%，相較之下，使用標準庫存裝置的病患翻修率為 16.6%。為了提供一些背景，在過去 25 年中，腰椎融合技術尚未發表數據證明在標準的兩年基準點上能顯著降低再手術率。

In contrast, aprevo patient-specific lumbar procedures have demonstrated clinically meaningful reduction in reoperations, driven by significant decreases in key complications like rod fractures and proximal junction kyphosis. Importantly, this improvement is measured against procedures with traditional stock fusion devices used by the most experienced and skilled surgeons.

相較之下，aprevo 以病患為中心的客製化腰椎手術已證實可在臨床上顯著降低再次手術率，主要來自於關鍵併發症（如連桿斷裂與近端交界後凸）的顯著下降。重要的是，這項改善是以最有經驗、技術最純熟的外科醫師所使用之傳統現成融合器械手術作為對照基準來衡量。

As a further expansion of our aprevo lumbar procedure, we have announced successful completion of the first aprevo bilateral lumbar fusion procedure in February. We are seeing great data in our limited market evaluation and are on track for our full commercial launch in the fourth quarter of this year.

作為我們 aprevo 腰椎手術的進一步延伸，我們已宣布於 2 月成功完成首例 aprevo 雙側腰椎融合手術。我們在有限市場評估中看到非常好的數據，並正按計畫於今年第四季全面商業上市。

Carlsmed's aprevo lumbar fusion technology has strong hospital reimbursement from CMS with all aprevo lumbar fusion procedures covered by 1 of 11 different MS-DRG codes. The majority of aprevo lumbar procedures are reassigned to the three elevated major complication or comorbidity MS-DRG codes. This provides hospitals with superior economic and clinical value to provide access to the aprevo procedure for patients.

Carlsmed 的 aprevo 腰椎融合技術在 CMS 方面具備強勁的醫院給付支持，所有 aprevo 腰椎融合手術皆可由 11 種不同的 MS-DRG 代碼之一涵蓋。多數 aprevo 腰椎手術會被重新歸類至三個「重大併發症或共病」的較高等級 MS-DRG 代碼。這使醫院在為病患提供 aprevo 手術可近性時，能獲得更優越的經濟與臨床價值。

On April 10, CMS published the FY '27 proposed rule for inpatient prospective payment system. Under this proposed rule, all aprevo lumbar spine fusion procedures would be reimbursed by one of three new MS-DRG codes. 523, 524 or 525 at a premium to traditional spine fusion procedures. If finalized as proposed, we see this development as very positive for patients, surgeons and hospitals to establish and maintain long-term access to the aprevo lumbar spine fusion procedure.

4 月 10 日，CMS 發布了 2027 會計年度（FY '27）住院前瞻性支付制度（IPPS）的擬議規則。依該擬議規則，所有 aprevo 腰椎脊椎融合手術將由三個新的 MS-DRG 代碼之一給付：523、524 或 525，且相較傳統脊椎融合手術享有溢價給付。若最終按擬議內容定案，我們認為此發展對病患、外科醫師與醫院皆非常正面，有助於建立並維持 aprevo 腰椎脊椎融合手術的長期可近性。

This published rule is preliminary. We anticipate the final rule to be published prior to becoming effective on October 1, 2026. Shifting to cervical. The first quarter 2026 represented our first full quarter in market commercially with the aprevo cervical fusion procedure, which we launched in December of 2025.

此一已發布的規則仍屬初步。我們預期最終規則將在 2026 年 10 月 1 日生效前發布。接著談頸椎。2026 年第一季是 aprevo 頸椎融合手術在市場上完整商業化的第一個完整季度；我們於 2025 年 12 月推出該手術。

With an estimated 370,000 cervical fusion procedures performed annually in the US, we believe that this additional growth lever can provide additional momentum in our business as a further extension of the aprevo platform. Cervical and lumbar spine fusion procedures are performed by spine surgery trained neurosurgeons and orthopedic surgeons alike.

美國每年估計進行約 37 萬例頸椎融合手術，我們相信這項額外的成長槓桿可作為 aprevo 平台的進一步延伸，為我們的業務帶來更多動能。頸椎與腰椎脊椎融合手術皆由受過脊椎外科訓練的神經外科醫師與骨科外科醫師執行。

Many of the spine surgeons perform both lumbar spine fusion and cervical spine fusion procedures, demonstrating a substantial procedural overlap across spine surgeons. We believe that we can leverage our team to train and onboard many of the surgeons already familiar with the lumbar aprevo technology platform on the aprevo cervical platform.

許多脊椎外科醫師同時執行腰椎與頸椎融合手術，顯示脊椎外科醫師之間存在相當大的手術重疊性。我們相信可運用團隊資源，將已熟悉腰椎 aprevo 技術平台的多位外科醫師，訓練並導入至 aprevo 頸椎平台。

In the early days of launch, we have already trained more than 20% of our surgeon users on the cervical platform. The aprevo cervical procedure is designed to address common causes of variable outcomes associated with anterior cervical discectomy and fusion, ACDF failure, including subsidence, malalignment and reoperations.

在上市初期，我們已在頸椎平台上訓練了超過 20% 的外科醫師使用者。aprevo 頸椎手術旨在解決與前路頸椎椎間盤切除融合術（ACDF）失敗相關、導致結果差異的常見原因，包括沉陷、對位不良與再次手術。

The procedure is designed to optimize bone contact surface area to improve load distribution, bone graft loading, preserve endplate strength, reduce subsidence risk and restore or maintain alignment. To complement aprevo cervical and achieve progress against some of these challenges in cervical fusions, our newly announced corra cervical plating system marks the debut of Carlsmed's patient-specific fixation portfolio and represents a fully personalized solution for ACDF procedures.

該手術設計用以最佳化骨接觸表面積，以改善載荷分布與骨移植負載、保留終板強度、降低沉陷風險，並恢復或維持對位。為了補強 aprevo 頸椎並在頸椎融合的部分挑戰上取得進展，我們新近宣布的 corra 頸椎鋼板系統標誌著 Carlsmed 病患客製化固定產品組合的首次亮相，並為 ACDF 手術提供完全個人化的解決方案。

The first procedure was performed in February 2026 at the University of California, San Francisco. We are progressing well with the limited market evaluation and are on track for the launch of corra cervical personalized plating system in Q4. Much like the lumbar aprevo procedure, the cervical aprevo procedure has a strong inpatient reimbursement profile.

首例手術於 2026 年 2 月在加州大學舊金山分校（UCSF）完成。我們在有限市場評估方面進展順利，並正按計畫於第四季推出 corra 頸椎個人化鋼板系統。與腰椎 aprevo 手術相似，頸椎 aprevo 手術也具備強勁的住院給付特性。

In October 2025, the aprevo cervical procedure received a new technology add-on payment up to an incremental $21,125 hospital reimbursement. This reimbursement program is for a three-year period and CMS renewed the NTAP payment for FY '27 as anticipated in the publication of the preliminary rule.

2025 年 10 月，aprevo 頸椎手術獲得新技術附加給付（NTAP），醫院可獲最高達額外 21,125 美元的增量給付。此給付計畫為期三年，且 CMS 如預期在初步規則的發布中，將 FY '27 的 NTAP 給付予以續期。

Looking ahead, our strategic focus remains consistent and positions us to continue the durable, high-quality growth we've demonstrated to date. Within our first area of focus, patient-centric innovation, we continue to advance our proprietary personalized surgery platform, including AI-enabled 3D surgical planning, workflow automation, patient and surgeon-specific devices and single-use sterile pack surgical instruments and further procedural integration in the clinic and operating room.

展望未來，我們的策略重點維持一致，使我們得以延續迄今所展現的穩健且高品質成長。在第一個重點領域「以病患為中心的創新」方面，我們持續推進自有的個人化手術平台，包括 AI 驅動的 3D 手術規劃、工作流程自動化、病患與外科醫師客製化器械、一次性無菌包手術器械，以及在門診與手術室中更深度的流程整合。

As discussed previously, we have demonstrated great early traction with the recent launch of aprevo Cervical, and we're collecting early clinical experience with the bilateral posterior aprevo procedure and personalized corra cervical plate fixation. Our product innovation portfolio includes further advancements to drive ease of integration in the surgical workflow and further personalization of spine surgery.

如先前所述，我們在近期推出 aprevo 頸椎後已展現良好的早期動能，並正累積雙側後路 aprevo 手術與個人化 corra 頸椎鋼板固定的早期臨床經驗。我們的產品創新組合亦包含進一步的改良，以提升在手術工作流程中的整合便利性，並推動脊椎手術更深層的個人化。

Our second area of strategic focus is surgeon education and includes further investments in our medical education team and programs to meet accelerating demand for aprevo personalized surgery. We continue training new surgeons every month by leveraging success in academic centers to drive peer-to-peer surgeon education with the thought leaders in personalized spine surgery.

我們第二個策略重點領域是外科醫師教育，包括對醫學教育團隊與計畫的進一步投資，以滿足對 aprevo 個人化手術日益加速的需求。我們持續每月訓練新的外科醫師，並藉由在學術中心的成功，與個人化脊椎手術領域的意見領袖推動同儕對同儕的外科醫師教育。

We also continue to support education initiatives with upcoming resident and fellow courses in partnership with leading academic institutions. As previously mentioned, we have seen strong uptake with early and mid-career surgeons that are adopting digital surgical planning into their practice in their efforts to streamline workflow and improve patient outcomes. These surgeon users will continue to shape the future of spine surgery, and this is an ongoing growth driver for Carlsmed that we believe will continue to drive adoption and utilization.

我們也持續支持教育倡議，並將與頂尖學術機構合作舉辦即將到來的住院醫師與研究員課程。如先前提及，我們看到職涯早期與中期的外科醫師對於將數位手術規劃導入其臨床實務有強勁採用，以期簡化工作流程並改善病患結果。這些外科醫師使用者將持續塑造脊椎手術的未來；我們相信這也是 Carlsmed 持續的成長驅動力，將繼續推動採用與使用量提升。

Our third area of strategic focus, commercial execution continues to center on surgeon onboarding, increasing surgeon utilization and expanding access within hospital systems. As we continue to scale, we've expanded our strategic and national accounts efforts to enable local and national access across large hospital systems.

我們第三個策略重點領域「商業執行」仍聚焦於外科醫師導入、提升外科醫師使用量，以及在醫院體系內擴大可近性。隨著我們持續擴張規模，我們已強化策略型與全國性客戶（national accounts）布局，以在大型醫院體系中實現地方與全國層級的可近性。

Across both lumbar and cervical platforms, hospitals are recognizing the clinical workflow benefits enabled by the aprevo ecosystem. By providing deeper integration within a surgeon's preoperative and postoperative clinical workflow, we believe that our platform solution can simplify the surgeon's pre-op planning, reduce time and complexity of the spine fusion procedure in the OR and enhance surgeon's ability to provide predictable outcomes to spine fusion patients.

在腰椎與頸椎兩大平台上，醫院正逐步認可 aprevo 生態系所帶來的臨床工作流程效益。透過在外科醫師術前與術後臨床工作流程中提供更深度的整合，我們相信平台式解決方案可簡化外科醫師的術前規劃、降低手術室中脊椎融合手術的時間與複雜度，並提升外科醫師為脊椎融合病患提供可預期結果的能力。

Lastly, we will continue to generate clinical data to support medical education and market adoption of our transformative personalized surgery technology platform. We believe that personalized surgery at scale is a new standard of care for spine fusion and are committed to providing solutions to patients, surgeons, and hospitals that reduce revision surgeries, improve outcomes and reduce the cost of health care. We're just getting started and look forward to providing further updates on our rapid market adoption.

最後，我們將持續產出臨床數據，以支持醫學教育與市場對我們具變革性的個人化手術技術平台之採用。我們相信可規模化的個人化手術將成為脊椎融合的新照護標準，並致力於為病患、外科醫師與醫院提供解決方案，以降低修正手術、改善結果並降低醫療成本。我們才剛開始，並期待就我們快速的市場採用提供更多更新。

With that, I'll turn it over to Leo, who will review our financial performance.

接下來我把時間交給 Leo，由他回顧我們的財務表現。

Thank you, Mike, and good afternoon, everyone. I'll begin today with first quarter 2026 P&L highlights. Revenue for the first quarter of 2026 was $16.1 million compared to $10.2 million in Q1 2025, representing 58% growth year-over-year. This growth was driven by the continued expansion of our total surgeon user base and increased unit volume sales of aprevo as our average revenue per procedure remained substantially consistent between periods.

謝謝你，Mike，各位下午好。我將先從 2026 年第一季損益表（P&L）重點開始。2026 年第一季營收為 1,610 萬美元，較 2025 年第一季的 1,020 萬美元成長，年增 58%。此成長主要來自我們外科醫師使用者總數的持續擴張，以及 aprevo 銷售單位量的增加；同時，我們每例手術的平均營收在兩個期間之間仍大致一致。

Gross margins were 77.1% in the first quarter of 2026 compared to 74.9% in the first quarter of 2025. This 220 basis points increase was driven by our stable average revenue per aprevo procedure, combined with efficiency improvements in our digital production system with investments made over the past few quarters.

2026 年第一季毛利率為 77.1%，相較 2025 年第一季的 74.9%。毛利率提升 220 個基點，主要受惠於 aprevo 每例手術平均營收的穩定，以及我們在過去幾季投資所帶動的數位化生產系統效率改善。

This now allows us to deliver the aprevo kit to the operating room within six business days of surgeon approval of the digital surgical plan. This lead time and the associated production capacity it enables will support our continued scale. Total operating expenses were $21.7 million in the first quarter of 2026 compared to $13.4 million in the first quarter of 2025. Of this amount, R&D expenses were $5.2 million this quarter compared with $3.2 million in Q1 2025.

這現在使我們能夠在外科醫師核准數位手術計畫後的六個工作天內，將 aprevo 套件送達手術室。此交期以及其所帶來的相關產能，將支持我們持續擴張規模。2026 年第一季的總營運費用為 2,170 萬美元，較 2025 年第一季的 1,340 萬美元增加。其中，本季研發費用為 520 萬美元，較 2025 年第一季的 320 萬美元增加。

This increase was primarily due to higher personnel costs to advance our patient-centric product development priorities and AI-enabled initiatives for our digital surgical planning processes. Sales and marketing expenses were $10.3 million this quarter compared with $6.7 million in Q1 2025.

此增加主要是由於為推進以病患為中心的產品開發優先事項，以及用於我們數位手術規劃流程的 AI 賦能計畫，而產生較高的人事成本。本季銷售與行銷費用為 1,030 萬美元，較 2025 年第一季的 670 萬美元增加。

This was substantially driven by increased sales headcount to drive our commercial execution strategy and variable commissions to our sales team and independent sales agents with our revenue growth as well as increased marketing spend. General and administrative expenses were $6.2 million this quarter compared with $3.5 million in Q1 2025.

這主要是由於增加銷售人力以推動我們的商業執行策略，以及隨著營收成長而提高對銷售團隊與獨立銷售代理的變動佣金，並且行銷支出增加所致。本季一般及行政費用為 620 萬美元，較 2025 年第一季的 350 萬美元增加。

The increase was driven by personnel additions and professional services costs and legal fees for customary corporate and intellectual property matters as well as compliance and other public company-related costs. Our GAAP net loss was $8.7 million this quarter compared to net loss of $5.7 million in the first quarter of 2025.

增加原因包括人員增補、專業服務成本，以及針對一般公司與智慧財產權事項的法律費用，另有合規及其他與上市公司相關的成本。本季我們的 GAAP 淨損為 870 萬美元，較 2025 年第一季淨損 570 萬美元擴大。

EBITDA adjusted for stock-based compensation was a negative $7.5 million this quarter compared to a negative $5.5 million during the first quarter of 2025. We anticipate continued improvement in adjusted EBITDA over the coming years, driven by expected revenue growth and leverage across our expense base. As we scale, expanding contribution margin dollars enabled by our capital-light digital-first business model provide a clearly modeled pathway towards cash flow breakeven.

剔除股權基礎薪酬後的調整 EBITDA 本季為負 750 萬美元，較 2025 年第一季的負 550 萬美元下降。我們預期未來幾年調整後 EBITDA 將持續改善，主要由預期的營收成長以及在費用基礎上的規模槓桿所帶動。隨著我們擴張，由我們資本輕量、數位優先的商業模式所帶來的貢獻毛利金額擴大，為邁向現金流損益兩平提供一條清晰且可建模的路徑。

Moving to our balance sheet. Our cash and investments as of March 31, 2026, totaled $97.1 million. The outstanding principal under our $50 million debt facility remains at $15.6 million. While we have no current plans to make additional draws ahead of its October 2030 maturity, this facility provides low-cost, non-dilutive standby capital and supports general corporate flexibility.

接著看資產負債表。截至 2026 年 3 月 31 日，我們的現金及投資合計為 9,710 萬美元。我們 5,000 萬美元債務融資額度下的未償還本金仍為 1,560 萬美元。雖然我們目前沒有計畫在 2030 年 10 月到期前再進一步動用該額度，但此融資提供低成本、非稀釋性的備用資金，並支持整體公司營運的彈性。

Total liabilities as of March 31, 2026, were $26.5 million, of which $15.6 million relates to this debt facility. Our cash used in operating activities was $13 million during the quarter compared to $8.2 million in the first quarter of 2025. Unlike traditional MedTech businesses that require capital investments in stock implant and instrument sets, our business scales without these barriers to profitability.

截至 2026 年 3 月 31 日，總負債為 2,650 萬美元，其中 1,560 萬美元與該債務融資額度相關。本季營運活動使用的現金為 1,300 萬美元，較 2025 年第一季的 820 萬美元增加。不同於需要在植入物與器械套組庫存上進行資本投入的傳統醫療科技企業，我們的業務擴張不受這些獲利障礙所限制。

As a pure-play personalized surgery company, our working capital could be more strategically deployed towards continued commercial investments to drive significant growth, delivery of our operational excellence priorities in digital production and continued R&D pipeline development for our business value and growth.

作為一家純粹的個人化手術公司，我們的營運資金可以更具策略性地配置於持續的商業投資以推動顯著成長、在數位化生產上落實我們的營運卓越優先事項，以及持續推進研發產品線的開發，以提升我們的業務價值與成長。

Turning to guidance. We are raising our full year 2026 revenue range to be between $72 million and $77 million in revenue, representing 48% growth at the midpoint over full year 2025. As we progress towards profitability, we continue to expect gross margins to remain in the mid- to high 70s and anticipate driving operating expense leverage in the coming quarters with expected revenue ramp in aprevo lumbar and cervical.

接著談展望。我們將 2026 全年營收區間上調至 7,200 萬至 7,700 萬美元，以中位數計較 2025 全年成長 48%。在邁向獲利的過程中，我們仍預期毛利率將維持在 70% 中段至高段，並預期隨著 aprevo 腰椎與頸椎業務的營收爬坡，在未來幾季帶動營運費用槓桿。

With that, I'll turn the call over to the operator for questions.

接下來我把電話交給接線員進行提問。

(Operator Instructions)

（接線員指示）

David Roman, Goldman Sachs.

David Roman，高盛。

Thank you. Good afternoon, everybody. I wanted just to start a little bit on what you're seeing from a surgeon utilization perspective. We did see strong surgeon adds exiting 2025. Can you maybe give us some perspective on how -- what you're seeing year-to-date qualitatively? And then how you're seeing utilization across both new and existing surgeons trend in the quarter and how you're thinking about the balance of the year?

謝謝。各位下午好。我想先從外科醫師使用情況的角度，了解你們目前看到的狀況。我們確實看到 2025 年底新增外科醫師表現強勁。你們能否從質性角度分享一下今年迄今你們看到的情況？另外，本季新舊外科醫師的使用率趨勢如何？以及你們如何看待今年剩餘時間的平衡？

Feel really good about our surgeon enthusiasm for the aprevo platform. And as we exited Q4 with a really strong new surgeon adds, we saw that continue to accelerate into the year. And as we discussed in the call, year-over-year, we've added about 60% increase to our surgeon users.

我們對外科醫師對 aprevo 平台的熱情感到非常振奮。在第四季結束時新增外科醫師非常強勁，而這股動能在今年持續加速。如同我們在電話會議中提到的，以年對年來看，我們的外科醫師使用者增加了約 60%。

With that, we continue to see ongoing increase in utilization, particularly those surgeon users that have gone through the initial trial process and continue through that adoption. So with that, we're really -- feel really good about the utilization and surgeon user adds that we've had.

同時，我們也持續看到使用率的提升，特別是那些已完成初期試用流程並持續採用的外科醫師使用者。因此，我們對目前的使用率以及外科醫師使用者新增的表現都感到非常有信心。

Got it. Got it. And then I think, Leo, in your prepared remarks, you mentioned that average selling prices for aprevo were roughly flat year-over-year. If I remember correctly, cervical procedures do come with lower ASP than lumbar. So can you maybe corroborate that point?

了解。了解。另外我想，Leo，在你事先準備的談話中，你提到 aprevo 的平均售價（ASP）年對年大致持平。如果我沒記錯，頸椎手術的 ASP 低於腰椎。你能否確認一下這點？

And then is it just that cervical isn't big enough as a percentage of total to move average ASPs? And how should we think about the weighted average selling price as cervical becomes a larger percentage of total going forward?

另外，是不是因為頸椎目前占總量的比例還不夠大，所以不足以拉動整體平均 ASP？隨著未來頸椎占比提高，我們應該如何看待加權平均售價的走勢？

Yes, David, this is Leo. So our Q1 average revenue per procedures were consistent over the prior year quarter in Q4 as well as Q1. So as we think about the future here and the combination of cervical and lumbar, we're projecting our average revenue per procedure to be in the mid- to high 20s as cervical takes a greater proportion of revenue over time.

是的，David，我是 Leo。我們第一季每例手術的平均營收，與前一年同期一致，且與第四季以及第一季的水準一致。展望未來，考量頸椎與腰椎的組合，隨著頸椎隨時間在營收中占比提高，我們預估每例手術的平均營收將落在 2 萬多美元的中段至高段。

And the average revenue per procedure for cervical is less than lumbar. So to answer your question directly, though the contribution margin and the ability for us to further scale our business on a single aprevo platform that serves both the lumbar and cervical indications with largely the same call point provides the operating leverage in our business to continue to scale and do so efficiently.

而頸椎的每例手術平均營收低於腰椎。因此直接回答你的問題：儘管如此，貢獻毛利以及我們在單一 aprevo 平台上進一步擴張業務的能力——該平台可同時服務腰椎與頸椎適應症，且在很大程度上使用相同的拜訪對象——為我們的業務帶來營運槓桿，使我們能持續擴張並且高效率地擴張。

Got it. Thanks so much.

了解。非常感謝。

Travis Steed, Bank of America.

Travis Steed，美國銀行。

Hi, this is [Aidan] on for Travis. So first full quarter of the cervical launch, can you talk about the puts and takes and how that's progressing? I think you said 20% of your surgeon users are now trained on that. What are you seeing from those accounts that have been trained so far? And then are we still expecting kind of high single-digit, low double-digit revenue contribution from cervical for the year? And I have a follow-up.

嗨，我是 [Aidan]，代 Travis 發言。頸椎產品上市後的第一個完整季度，你們能談談其中的利多利空因素，以及目前進展如何嗎？我想你們提到目前約有 20% 的外科醫師使用者已接受相關訓練。對於目前已受訓的這些客戶，你們觀察到什麼情況？另外，我們是否仍預期今年頸椎對營收的貢獻大約是高個位數到低雙位數百分比？我還有一個追問。

Yes, we feel really good about the traction that cervical has received here in the first quarter of launch. And as we -- as reported, as you mentioned, about 20% of our total lumbar users are now trained on cervical and going through the ramp. As we see this progression, high single-digit, low double-digit percent contribution of revenue from cervical in the total plan for the company looks about right.

是的，我們對頸椎在上市第一季所獲得的市場牽引力感到非常滿意。如同我們所報告、也如你提到的，目前約有 20% 的腰椎使用者已接受頸椎訓練並正在爬坡。依照目前的進展，頸椎在公司整體計畫中對營收的貢獻落在高個位數到低雙位數百分比，看起來是合理的。

Great. And then in the Q, I did call out cost improvements and production fees charged by your contract manufacturer. Can you double-click on that and talk about if that's a onetime? Or is this something we can expect to continue going forward?

很好。另外，在本季你確實提到成本改善，以及合約製造商向你們收取的生產費用。你能更深入說明一下嗎？這是一次性的嗎？還是我們可以預期未來會持續？

Yes. We've made investments in our digital production system holistically that's allowed us to hit that 6-day lead time. That really provided efficiencies in our production process, inclusive of those with our contract manufacturer. But the investments made in those earlier quarters going back to Q3 of 2025 now allow us to cut out cost and time importantly out of the system. So what we are currently reporting in that high 70s gross margin, we see to be sustainable.

是的。我們已從整體面向投資於數位化生產系統，使我們能達成 6 天的交期。這確實為我們的生產流程帶來效率提升，也包括與我們的委外代工製造商之間的流程。但先前幾個季度所做的投資（可追溯至 2025 年第 3 季）如今讓我們能夠在系統中關鍵性地削減成本與時間。因此，我們目前所揭露的 70% 高段毛利率，我們認為是可持續的。

(Operator Instructions)

（接線員指示）

Richard Newitter, Truist Securities.

Richard Newitter，Truist Securities。

Hi, thank you for taking the questions. Congrats on the quarter. I wanted to just go to the CMS proposal that just came out. I think you had mentioned the premium and also broader coverage. I think in the past -- and those are two things that I think could be pretty significant tailwinds for you in 2027, assuming everything goes as proposed into the final rule.

嗨，謝謝讓我提問。恭喜本季表現。我想談談剛出爐的 CMS 提案。我記得你提到保費（premium）以及更廣泛的給付範圍。我想過去——而這兩點我認為若最終規則如提案所示落地，對你們在 2027 年可能會是相當重要的利多。

So I guess just on what percentage would you say of your procedures currently are generally getting reimbursed and covered consistently? And kind of how much would this broaden that coverage swath, if you will? And then just on the premium, I think we did some calculations, and we're estimating it could be an incremental $50,000 reimbursement for stock implants on average.

所以我想問的是，你們目前的手術中，大約有多少比例一般而言是能夠獲得報銷且給付相對一致的？以及這項提案大概會把給付覆蓋面擴大多少？另外關於保費，我想我們做了一些計算，估計對於現成（stock）植入物而言，平均可能會增加約 50,000 美元的報銷額。

Obviously, there's a big range in there. I think that's somewhere around $25,000 to $30,000 on average today above and beyond or the premium to your traditional stock implants. Is that ballpark kind of the math that you guys have worked out?

當然，這裡面的區間很大。我想以目前平均來看，大約是 25,000 到 30,000 美元，作為相對於傳統現成植入物的額外部分或保費。這個區間大致上符合你們算出來的數字嗎？

Hi, Rich, thanks for the questions. I kind of talk about this in two parts. First, the current state of reimbursement for the aprevo lumbar platform. As reported in the script, we currently have 11 different MS-DRGs that cover the aprevo lumbar platform, all with existing coverage and reimbursement.

嗨，Rich，謝謝你的問題。我大致分兩個部分來談。第一是 aprevo 腰椎平台目前的報銷狀況。如逐字稿所述，我們目前有 11 個不同的 MS-DRG 涵蓋 aprevo 腰椎平台，且都已有既有的給付與報銷。

As noted, a portion of those elevate to a higher-paying DRG today. With the proposed IPPS rule, it really simplifies the coding and reimbursement that all aprevo procedures would map to one of three different MS-DRGs. And based on your calculations, that seems about how it would look on a national average. And so we agree. We think this is a really great solution that CMS is proposing to give significant reimbursement to these procedures.

如前所述，其中一部分目前會提升到支付更高的 DRG。在擬議的 IPPS 規則下，編碼與報銷將大幅簡化，所有 aprevo 手術都會對應到三個不同 MS-DRG 之一。依照你的計算，從全國平均來看大致會是那樣的結果。因此我們同意。我們認為 CMS 所提出、為這些手術提供顯著報銷的方案非常好。

That's great. And then just what could it do in terms of the -- where you're potentially meeting resistance or there's just not great coverage currently? What could this do for you from that standpoint? Is it 50% currently? Is it 80%? Like just give us a sense as to how this could broaden your coverage and access.

太好了。那麼就你們可能遇到阻力、或目前給付並不理想的地方而言，這會帶來什麼影響？從那個角度看，這對你們會有什麼幫助？目前是 50% 嗎？是 80% 嗎？請給我們一些概念，這可能如何擴大你們的給付覆蓋與可近性。

Yes. We really look at this as access versus coverage because we have full coverage today where we really think this will provide value to hospitals, in particular, is to remove the ambiguity and actually simplify coding for the aprevo procedure. And so we see this as very beneficial to the hospitals to simplify the process so that they can code procedures as they normally would and know that they'll map the right MS-DRG.

是的。我們更把這看作是「可近性」而非「給付覆蓋」，因為我們今天其實已經是全面給付；我們認為這將特別為醫院帶來價值之處在於，消除不確定性並實際簡化 aprevo 手術的編碼。因此我們認為這對醫院非常有利，可簡化流程，讓他們能像平常一樣為手術編碼，並確信會對應到正確的 MS-DRG。

Okay. That's really helpful. If I could squeeze one more in. Just following up to David's question earlier. As cervical increases as a percentage of the mix moving through the year, just Leo, how should we think of the gross margin impact if revenue per procedure gets impacted the gross margin, too, I would imagine. So just if you could give us anything on the cadence as we move through '26 that you'd want to call out 2Q to 4Q?

了解。這很有幫助。如果我可以再塞一個問題。接續先前 David 的問題。隨著頸椎（cervical）在今年內占比提高，Leo，我們應該如何看待毛利率的影響？如果每例手術的收入受到影響，我想毛利率也會受到影響。所以如果你能談談 2026 年推進過程中的節奏，特別是 2Q 到 4Q，有沒有什麼你想提醒的？

Yes. So as we mentioned during our prepared remarks earlier, we see gross margins being in the mid- to high 70s over the coming quarters. That factors in, as Mike covered earlier, a high single-digit, low double-digit mix between lumbar and cervical.

是的。如同我們在先前準備稿中提到的，我們預期未來幾個季度毛利率將落在 70% 中段到高段。這也納入了 Mike 先前提到的因素：腰椎與頸椎之間的組合占比約為高個位數到低雙位數。

So the headwinds with the lower gross margin profile of cervical, notwithstanding the tremendous contribution margin it provides and the leverage it provides in our business is going to be offset as we see it with our efficiencies in digital production for lumbar.

因此，儘管頸椎的毛利率結構較低會帶來逆風，但考量其帶來的可觀貢獻毛利（contribution margin）以及對我們業務的槓桿效益，我們認為這些影響將會被我們在腰椎數位化生產效率的提升所抵銷。

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

Hi, this is Izzy, on for Ryan. Mike, I heard your comments and all the discussion around the IPPS proposal for 2027. I was just curious what you have heard in terms of feedback from your hospital customers and surgeons in reaction to the proposal? And do you -- I know it's going to simplify coverage, but do you expect that there could be some benefit in terms of volumes if it's proposed as written?

嗨，我是 Izzy，代 Ryan 提問。Mike，我聽到你對 2027 年 IPPS 提案的評論以及大家的討論。我想了解一下，你從醫院客戶與外科醫師那邊聽到對這項提案的回饋是什麼？另外，你們——我知道這會簡化給付，但如果最終如提案文字所寫，你是否預期在手術量（volumes）方面也可能有一些好處？

Thanks for the question. It's early days, and it is preliminary rule. And so we're really holding off on those discussions until the final rule goes into place. However, this is something that, as mentioned, simplifies coding, simplifies reimbursement and makes a permanent change to the aprevo procedure at a higher reimbursement level. So net-net, we think this is better for all stakeholders.

謝謝你的問題。目前還在初期階段，而且這是初步規則。因此，在最終規則正式落地之前，我們會先暫緩進行那些討論。不過，如同提到的，這會簡化編碼、簡化報銷，並以更高的報銷水準對 aprevo 手術做出永久性的變更。總而言之，我們認為這對所有利害關係人都更好。

Appreciate it. And then, Leo, I've heard your commentary on guidance. But as we consider contribution layering in the back half of the year from those new product launches, is there anything that we need to keep in mind in terms of phasing on the top line?

了解，謝謝。另外，Leo，我聽到你對財測（guidance）的評論。但當我們考量下半年那些新產品上市所帶來的貢獻逐步疊加時，在營收端的分期（phasing）方面，有沒有什麼我們需要留意的？

Yes. Look, we see over -- in the coming quarters, aprevo lumbar to carry the majority of our revenue and overall contribution. Certainly, we're very pleased with the early days here of cervical and the clinical results our surgeons are seeing with that indication, how neatly it tucks into the aprevo platform and ecosystem.

是的。你看，我們預期在接下來幾個季度，aprevo 腰椎仍將貢獻我們大部分的營收與整體貢獻。當然，我們對頸椎在早期階段的表現非常滿意，也對外科醫師在該適應症上看到的臨床結果感到振奮；它也非常順暢地融入 aprevo 平台與生態系。

We'll provide additional color as we progress in the quarter -- in the subsequent quarters with how we see additional things shaping up for the company's favor to further drive revenue beyond what we previously guided.

隨著本季推進——以及接下來幾個季度——我們會提供更多細節，說明我們如何看待更多事項朝對公司有利的方向發展，進一步推動營收超越我們先前所給出的指引。

This concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. And you may now disconnect.

問答環節到此結束。感謝各位參與今天的電話會議。本次會議也到此結束。各位現在可以掛線。